Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 207739
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | AO | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/17/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUPHENAZINE DECANOATE
INJECTABLE;INJECTION; 25MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 207739 | AUROBINDO PHARMA LTD |
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 071413 | FRESENIUS KABI USA |
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 075918 | MYLAN LABS LTD |
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 203732 | PAR STERILE PRODUCTS |
| FLUPHENAZINE DECANOATE | FLUPHENAZINE DECANOATE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 074531 | WEST-WARD PHARMS INT |
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